This randomized early phase I trial is studying different formulations of SR13668 in healthy volunteers. Giving SR13668 may help doctors learn more about how SR13668 is used by the body. It is not yet known which formulation of SR13668 is most effectively used by the body.

Food effect on the bioavailability of SR13668 after oral administration [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: No ]

The first stage will be used to compare fed vs. fasted diet effect on the pharmacokinetics parameters under formulation 1.

Formulation effect on the bioavailability of SR13668 after oral administration [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: No ]

The second stage will be used to determine the formulation effects on the pharmacokinetics parameters, all under either fed or fasted diet as determined by the first stage.

Secondary Outcome Measures:

Solubility and stability of Akt inhibitor SR13668 in oral formulations selected for exploratory pharmacokinetics studies [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: No ]

Oral pharmacokinetics of a single low dose of Akt inhibitor SR13668 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: No ]

Metabolism of Akt inhibitor SR13668 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: No ]

Preliminary safety data for Akt inhibitor SR13668, graded according to NCI CTCAE version 3.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]

Participants complete an overnight fast of ≥ 10 hours, eat a high-fat (approximately 50% of total caloric content of the meal) and high-calorie (approximately 800-1,000 calories) meal, and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug administration.

Drug: Akt inhibitor SR13668

Given orally as a single dose

Other Name: SRI13668

Experimental: Arm II

Participants complete an overnight fast of ≥ 10 hours and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug administration.

STAGE 1 (for the first 6 participants enrolled in the study [closed to accrual as of August, 2009]): Participants are randomized to 1 of 2 arms.

ARM I: Participants complete an overnight fast of ≥ 10 hours, eat a high-fat (approximately 50% of total caloric content of the meal) and high-calorie (approximately 800-1,000 calories), and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug administration.

ARM II: Participants complete an overnight fast of ≥ 10 hours and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug administration.

STAGE 2 (for the next 12 participants enrolled in the study): The preferred dietary condition (Arm I) identified in stage 1 is used. Participants are randomized to 1 of 4 arms.

Psychiatric illness or social situation that would limit compliance with study requirements

No diabetes mellitus

No other condition that may, in the investigator's opinion, interfere with ingestion or absorption of oral medications (e.g., inflammatory bowel disease)

No history of allergic-type reactions, including asthma and urticaria, or other intolerance to chemical compounds similar to the active study agent, indole-3-carbinol, or cruciferous vegetables (e.g., cabbage, cauliflower, broccoli, kale, and Brussels sprouts)

More than 14 days since prior and no concurrent anticoagulant or antiplatelet medications

More than 7 days since prior and no concurrent daily medications or nutritional supplements

No prior gastrectomy that may, in the investigator's opinion, interfere with ingestion or absorption of oral medications

No other concurrent medications

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896207